1. Field of the Invention
The present invention relates to fluid dispensing systems, move particularly, fluid infusion systems for repeatedly injecting a predetermined amount of a fluid into the vascular system of a patient through a catheter.
2. The Relevant Technology
A reasonably common and dangerous medical condition arises when a blood clot develops in the vascular system of the body of a patient. A blood clot or thrombus can endanger the health of a patient in at least two significant ways. First, the clot may restrict or even completely stop essential blood flow to a portion of the patient's body. If the blood flow to the brain or heart for example is restricted the patient's life may be placed in jeopardy. Additionally, a clot may break loose from the site at which it formed and be carried by the blood stream to an organ, such as the heart or the lungs, where it may cause irreparable damage or even death. Accordingly, when a blood clot is detected, it must be quickly and effectively treated.
One method involves surgery to remove the clot and repair the blood vessel. A less invasive method uses thrombolytic drugs to break up, or lyse, the thrombus. This method of treating a blood clot consists of inserting a catheter into the patient's vascular system, preferably near the site of the clot. If the catheter enters the vascular system near the clot, the catheter alone may be used. If, for a variety of reasons, the catheter must be inserted into the vascular system at a distance from the clot, placement of the catheter may be aided by using an introducer sheath and a guide wire, which can be used to push and guide the catheter through the vessels or arteries of the vascular system to reach the clot.
Once the catheter is positioned at the site of the clot, a thrombolytic fluid capable of dissolving the clot, such as urokinase or streptokinase, is delivered to the site of the clot by means of the catheter. Conventional catheters have a lumen, i.e., an internal passage, that allows the thrombolytic fluid to flow through the catheter to one or more discharge openings at or near the distal end of the catheter. The discharged thrombolytic fluid then dissolves or lyses the clot, thus removing the danger to the patient. In addition, the mechanical force of the fluid spraying out of the openings can also help to break up the thrombus.
Not all clots are easily or successfully lysed. Some clots form around arterial lesions, which clots may not be easily lysed or broken up by the thrombolytic fluid and which usually require surgical removal. Additionally, some clots may be extremely thick, extending for a relatively long distance through a blood vessel of the circulatory system. Such a thick clot may require considerable amounts of time and heavy irrigation of thrombolytic fluid to dissolve.
Typically, a guidewire is used in conjunction with a catheter to facilitate placement of the catheter. The guidewire can also serve to penetrate the clot in order to form a passage therethrough so that the catheter can be inserted within the interior of the clot. This helps to ensure that the thrombolytic fluid is concentrated or focused at the location of the clot, since excessive thrombolytic fluid in the bloodstream can have adverse effects on the patient.
After the guide wire has been used to create a narrow passage through the clot, particularly a thick clot, the thrombolytic fluid is released through the one or more openings within the catheter. In the beginning stages of thrombolytic therapy, thrombolysis was carried out using a catheter with a single opening at the distal end of the catheter. Methods employing a simple catheter required movement of the catheter from one end of the clot to the other while dispensing the thrombolytic fluid in order to adequately distribute the fluid over the entire length of the thrombus.
Subsequent attempts have been made to improve the dissolution of blood clots by forcefully injecting a dissolving agent simultaneously along the length of the blood clot. In one such approach, the catheter has a large tip opening and a plurality of small side opening positioned at the distal end of the catheter. The tip opening is used for placement of the catheter. Initially, a long thin guide wire is slid into the vascular system such that the distal end of the guidewire extends through the blood clot. Next, the end of the guidewire outside the body of the patient is received within the tip opening of the catheter. The catheter is then slid over the guidewire, while holding the guidewire stationary, until the side openings in the catheter are positioned within the blood clot. Once the catheter is positioned, the guidewire is removed while holding the catheter stationary.
To force the dissolving agent to pass through the side openings in the catheter, it is first necessary to block or occlude the large tip opening. This is accomplished by inserting a thin placement wire having an enlarged occluding ball at the distal end thereof into the end of the catheter outside of the patient. The placement wire is advanced until the occluding ball is sealingly disposed at the tip opening. With the placement wire still inside the catheter, the proximal end of the catheter is fluid coupled with a two syringe pumping system for injecting the dissolving agent into the catheter and out through the side openings thereof.
The syringe system includes a conventional first syringe coupled to one end of a valve housing having a pair of opposing check valves formed therein. The opposing end of the valve housing is coupled to the proximal end of the catheter. A conventional second syringe is filled with the dissolving fluid and is coupled to the side of the valve housing. As the plunger of the first syringe is manually drawn back, fluid is drawn from the second syringe into the first syringe. A first check valve within the valve housing blocks communication with the catheter to prevent body fluid from being sucked into the catheter, and into the first syringe. Once a sufficient amount of dissolving fluid is drawn into the first syringe, the plunger thereof is pushed forward. Simultaneously, the first check valve is opened and a second check valve, which block access to the second syringe, is closed. As a result, the dissolving fluid is dispensed into the catheter and out through the side openings, thereby forcefully flowing against the blood clot. The process is then continually repeated by again manually pulling back and advancing the plunger of the first syringe until the blood clot is dissolved. Treatment may take from 50 to more than 250 injections depending on the protocol used.
Although useful, there are several shortcomings associated with the above described system. For example, since the catheter tip is located within the body of the patient, it is difficult for the surgeon to determine when the occluding ball of the placement wire is approaching the catheter tip. Although the tip is slightly tapered for seating of the occluding ball, if the surgeon pushes too hard on the occluding wire, the occluding ball can be pushed through the tip opening. If this happens, the catheter and placement wire must be removed and the process of placement repeated.
Furthermore, to ensure that the proper amount of dissolving agent is dispensed through the first syringe, the person administering the treatment must carefully measure the amount of dissolving fluid that is drawn into the syringe. This delicate measuring must be performed each time an injection is made, as there is variability from dose to dose. As a result of this required measuring, the rate at which the fluid is dispensed is substantially reduced. If too much dissolving fluid is drawn into the first syringe, the first syringe must be removed from the valve assembly in order to dispense the excess fluid. In this case, the excess fluid, which is very expensive, is lost. Furthermore, having to remove and reattach the first syringe increases the likelihood of introducing an air bubble into the system. The introduction of an air bubble into the vascular system can be life threatening.
An additional problem with the above system is that filling the first syringe typically requires two hands. That is, one hand holds and stabilizes the barrel of the syringe while the other hand pulls back the plunger. The use of two hands is further necessitated by the fact that the first syringe must be filled to an exacting amount as discussed above. The requirement that the surgeon use both hands to operate the first syringe and that the surgeon continually concentrate on the first syringe to insure that the first syringe is not over filled, limits the ability of the surgeon to simultaneously perform other tasks, such as stabilizing the catheter and concentrating on the status of the patient.
Yet another problem with the above syringe system is that conventional syringes dispense by compressing the plunger with the thumb while holding the barrel with the index and middle finger. Although such a system is fine for singular doses, it is preferred in the present system to repeatedly inject the dissolving fluid at short intervals and under high pressures. By using only two fingers and a thumb to operate the first syringe, only minimal pressure can be produced. Furthermore, the hand quickly tires and cramps by using such small and isolated muscles.
The configuration of the above syringe system is also less than optimal. For example, the first and second syringes as discussed above are long narrow plastic syringes that project at rights angles to each other with their nozzles closely connected. Each syringe is rigidly connected to the valve assembly. In light of the repeatedly applied force to the first syringe, the positioning of the second syringe relative to the first syringe enhances the risk that the second syringe could be broken off or come loose from the valve assembly. For example, should the surgeon slip during pumping of the first syringe or make any fast hand movements, the surgeon could unintentionally catch the second syringe and potentially break it off.
Finally, yet another problem with the present system is that as a result of the multiple syringes and check valves, it is difficult to debubble the system. That is, all air must be removed from the system prior to injection of the fluid into the vascular system. Debubbling of the prior art system can require relatively large amounts of dissolving fluid to be run therethrough to ensure that the air bubbles are removed. Such fluid can be very expensive and wasteful. The use of two check valves also increases the number of moving parts and thus increase the likelihood of mechanical failure.